DeviceClearance

Product code DXP— Cardiovascular

TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT

Classification name
Transducer, Vessel Occlusion
Device class
Class 2
Regulation
21 CFR 870.2890
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

Market context for product code DXP

FDA has cleared 2 devices under product code DXP between 1981 and 1989, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code DXP

Recent clearances under product code DXP

Data sourced from openFDA. This site is unofficial and independent of the FDA.